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FDA PRODUCT CODE · CLASS I

QYN — Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)

An AVS is a prescription use device intended for temporary pain relief and is used adjunctively with other pain therapies

DEVICE CLASS
Class I
REGULATION
21 CFR 890.5775
MEDICAL SPECIALTY
Physical Medicine
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
510k: 1
0
RECALL ENTRIES

Recent clearances

DEN250005Sana Health · 510k2026-01-16

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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